Jake Krembil, COOMany researchers and biotech organizations sought to combat this problem and craft affordable solutions that helped improve patient care delivery. A handful of these players got close to cracking the code, panCELLa however made headway faster than the rest with its allogeneic cell therapy expertise. Allogeneic cell therapies follow a more one-for-all doctrine. Provided good manufacturing practices (GMP) are followed strictly, allogeneic therapy can be delivered to patients en masse, where the stem cells are collected from one healthy donor. These cells are free of any infectious contaminants, giving healthcare professionals and pharmaceutical organizations a much broader scope in patient care delivery and large-scale production. The main goal for the biotechnology industry, with the allogeneic approach, is delivering off-the-shelf stem cell therapy solutions to aid millions across the globe. panCELLa recognized this fast-shifting pattern early on and, backed by the most prominent minds in the field, dedicated itself to spearheading allogeneic solution innovation. It may be a small company, but it is very nimble in its operations with a ‘try before you buy’ business model. It is this very characteristic that allows the company to compete with some of the largest brands in the arena, showcasing its pride as a Canadian biotechnology innovator.
The company is co-founded by Dr. Andras Nagy, Ph.D., and Armand Keating, MD, Ph.D., two renowned experts in stem cell biology, clinical research, and hematology. Their combined experience and passion have led them to establish one of the most promising earlystage biotechnology research companies that seek to further the world's understanding of stem cell therapy from a clinical applications perspective.
"The idea behind founding the company was to have one cell that would deliver therapies to everyone," expresses Dr. Mahendra Rao, chairman of panCELLa. Patients would no longer have to depend on immunosuppressants and complementing drugs, avoiding many stressors that would otherwise curtail their quality of life.
An integral participant in establishing Canada's first human embryonic stem (hES) cell lines, Dr. Nagy discovered a non-viral method of creating stem cells from other cells within the human body. The finding shows much potential in fast-tracking the development and large-scale production of cures for life-threatening conditions alongside therapies for spinal cord injuries, macular degeneration, and Parkinson's.
The foundations of panCELLa were built on two platforms created by Dr. Nagy to deliver effective allogeneic cell treatment. The combination of FailSafeTM and induced Allogeneic Cell Tolerance (iACT) helps researchers tackle the hurdles set up by malignant tumors. Unfortunately, the cause of these growths is traced back to the ongoing cell-based therapies administered to patients initially. The stem cell graft could fail and lead to excessive cell duplication, resulting in teratomas. FailSafeTM, panCELLa's flagship offering, equips researchers and biotechnology professionals with more control over the cell therapies they manage. As a result, the promise of safety can be provided more confidently.
The idea behind founding the company was to have one cell that would deliver therapies to everyone
The company's platform links the stem cell expressions to be grafted with a cell division essential locus (CDEL). Through this process, panCELLa can target the proliferating or misbehaving cells and leave the rest to FailSafeTM. "It's a suicide switch," states Dr. Rao.
FailSafeTM expresses a gene, HSVTK, and an FDA-approved prodrug called Gancivlovir in tandem with cell therapy. This suicide gene is programmed to induce cell death, arresting any malignant growths. FailSafeTM was built to ensure uninterrupted cell therapies, and panCELLa's highly qualified staff of healthcare professionals has delivered on their vision. The innovative iACT solution—an immunity suppression technology—cloaks grafted stem cells and helps them stay under the recipient's immune system radar; the patient's body will not react with hostility. panCELLa empowers its patrons with better control over these cells to mitigate any risks during treatment.
With these two groundbreaking platform technologies, the company has supported a host of clients and partners across Canada since 2015. The vast clinical experience of its management also allows panCELLa to provide valuable assistance from the initial stages of research through to clinical trials. "Our company prioritizes relationships. We work to build connections with our partners and industry leaders to provide a well-rounded service to our clients" states Jake Krembil, COO of panCELLa. The company thus has been able to develop its solutions—all while licensing freedom-to-operate (FTO) technologies—with a comprehensive understanding of a client's science and objectives at a granular level.
panCELLa applies ex vivo gene engineering to create its allogeneic stem cells. In this process, and subscribing to a relatively new approach in the market, the company utilizes pluripotent cells—found in the cell mass of the human embryo— instead of adult cells, which is the traditional practice. Due to their self-healing properties, pluripotent cells are naturally immortal, making them an inexpensive option. After creating a new stem cell culture, panCELLa takes it to a contract development and manufacturing company (CDMO) and manufactures it at scale, adhering to standardized manufacturing methods. The cells can be differentiated in the same place and then administered to a patient in a well-equipped clinic or hospital via IV or intra-arterial injections. Such methodologies followed by the company have proven to be beneficial from a monetary perspective for clients, all while offerings researchers and clinical professionals improved quality control over the cells.
The FailSafeTM and iACT platforms forecast a wide range of drug development application areas, including bio-production, cancer vaccination, and tolerization. panCELLa intends to make each of its product offerings easily accessible to people everywhere, highlighting its holistic, hopeful outlook toward the future of medicine. The firm goes beyond the call of duty and presents clients with a non-exclusive licensing policy that allows big and small companies to access its technology. Researchers who incorporate the company's technology into their products can use them in the clinic without having to worry about signing any additional licenses. panCELLa has purchased several licenses for gene technologies, such as CRISPR, and presents clients with the opportunity to access leadingedge technologies and further de-risk the initial evaluation steps of their research and patenting processes. panCELLa emphasizes carrying out straightforward communication with each client and, depending on the progress they make, openly discusses the various agreements and contracts that may follow.
To help clients achieve successful and expeditious commercialization of their pharmaceutical products, panCELLa strived to gather detailed insights about the biotech landscape and today has developed the necessary technologies to support stem cell therapy research. The company has established two subsidiaries to help the industry simplify its advance toward next-gen therapeutics. The firm is focused on driving Canada's footprint in the global marketplace as an active and fast-progressing realm that is soon to revolutionize the world with the innovations it currently inculcates.
